Quality Systems

Articles

The company is voluntarily recalling one batch of Semglee prefilled pens because of a potential missing label.

Mylan Recalls Semglee Prefilled Pens

The company is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups because of microbial contamination. 

Lohxa Recalls Senna Syrup

Editor of Pharmaceutical Technology Europe

Particle analysis provides assurances of the quality and performance of the final dosage form in pharmaceutical development.

Without a Particle of Doubt

Feliza Mirasol is the science editor for 

Sample preparation tends to be manually labor intensive, but automating this step helps streamline the glycosylation monitoring workflow.

Automation Helps Streamline Glycosylation Monitoring Workflow

Hari Narayanan, PhD, is product marketing manager at Thermo Fisher Scientific.

Persistent bottlenecks in biocatalyst development can be alleviated through fully automated enzyme analysis.

Advancing Enzyme Analysis Through Automation

Richard J. Forsyth is principal consultant with Forsyth Pharmaceutical Consulting, 907 Shamrock Ct, Royersford, PA 19468, tel. 484.535.1688, forsythpharmaconsulting@gmail.com.

Dr. Sabine Imamoglu is Product Supply, Pharmaceuticals, Pharmaceutical Affairs, Bayer AG.

Continued process verification for a cleaning validation program begins once the validation study is complete. 

Continued Process Verification for Cleaning Validation– Challenges and Pitfalls

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority. 

Quality Still a Priority

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Siegfried Schmitt, vice president Technical at Parexel, discusses the difficulty of operating non-GMP and GMP quality systems in the same facility.

Good Manufacturing Practice on Demand?

Lynn D. Torbeck is an international consultant and trainer specializing in applied statistics and experimental design for pharmaceutical, biopharmaceutical, and medical device research and development, validation, quality control/assurance, and production, 2000 Dempster Plaza, Evanston, IL 60202, tel. 847.424.1314.

Chuck Pheatt is Professor Emeritus with Emporia State University.

The authors introduce the idea of asymmetrical tolerance intervals as an aid in fully assessing product performance relative to product or process requirements.  

Using Tolerance Intervals to Assess Conformance to Requirements

Particle analysis is a critical component of pharmaceutical development, providing assurances of the quality and performance of the final dosage form.

Quality Assurance/Quality Control